000 03976nam a22005417a 4500
008 170411s20162016 xxu||||| |||| 00| 0 eng d
022 _a0002-8703
040 _aOvid MEDLINE(R)
099 _a27297851
245 _aA randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.
251 _aAmerican Heart Journal. 177:66-73, 2016 Jul
252 _aAm Heart J. 177:66-73, 2016 Jul
253 _aAmerican heart journal
260 _c2016
260 _fFY2017
266 _d2017-05-24
501 _aAvailable online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
520 _aCONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.
520 _aCopyright � 2016 Elsevier Inc. All rights reserved.
520 _aDESIGN: Double-blind, placebo-controlled, multicenter randomized trial.
520 _aINTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 mug/[kg min]) or placebo for 24-48 hours.
520 _aMEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction.
520 _aOBJECTIVE: Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes.
520 _aSETTING: Tertiary care hospitals.
546 _aEnglish
650 _a*Cardiac Output, Low/th [Therapy]
650 _a*Cardiotonic Agents/tu [Therapeutic Use]
650 _a*Hydrazones/tu [Therapeutic Use]
650 _a*Intra-Aortic Balloon Pumping
650 _a*Postoperative Complications/th [Therapy]
650 _a*Pyridazines/tu [Therapeutic Use]
650 _aAcute Kidney Injury/ep [Epidemiology]
650 _aCardiac Output, Low/mo [Mortality]
650 _aCardiac Surgical Procedures/mo [Mortality]
650 _aDouble-Blind Method
650 _aHumans
650 _aInfusions, Intravenous
650 _aIntensive Care Units
650 _aLength of Stay/sn [Statistics & Numerical Data]
650 _aPostoperative Complications/mo [Mortality]
650 _aRespiration, Artificial
651 _aMedStar Heart & Vascular Institute
657 _aJournal Article
700 _aLipinski, Michael J
790 _aAlvaro G, Amantea B, Auci E, Auriemma S, Baiocchi M, Bianchi A, Biondi-Zoccai G, Bove T, Bradic N, Buscaglia G, Calabro MG, Cariello C, Corcione A, De Vuono G, Fominskiy E, Frontini M, Galdieri N, Gemma M, Gianni S, Grigoryev E, Guarracino F, Landoni G, Lembo R, Likhvantsev V, Lipinski MJ, Lobreglio R, Lomivorotov VV, Monaco F, Pala G, Paternoster G, Pisano A, Sangalli F, Wang CY, Zangrillo A, Zucchetti MC
856 _uhttps://dx.doi.org/10.1016/j.ahj.2016.03.021
_zhttps://dx.doi.org/10.1016/j.ahj.2016.03.021
942 _cART
_dArticle
999 _c2410
_d2410